Novo Nordisk Annual Report 2021
Contents Introducing Novo Nordisk
Strategic Aspirations
Key risks
Management
Consolidated statements
Additional information.
Novo Nordisk Annual Report 2021 25
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Towards holistic, integrated healthcare
Our Research and Development (R&D) strategy has led us to
a point in time where we now have more clinical programmes
with more participants than at any time in our 99-year history.
To make this possible, we have re-organised R&D operations,
creating a Research & Early Development unit to fuel and
validate our early pipeline, and a patient solutions-focused
Development organisation to take our most promising
candidates forward.
Throughout this work, we are focused on the power of
digitalisation and connected healthcare. We are evolving
from a molecule-focused pharmaceutical company to a
patient solutions-oriented enterprise where drug, device,
digital, diagnostics and data are fully integrated to deliver
leading treatment solutions to patients. This '5D' approach will
bring improvements right along the value chain, from more
convenient and better products and devices for patients - who
can check and track their health status in real time via apps and
other systems - to faster, more efficient product development.
Our electronic Patient Interaction Device, for example, allows
the collection of real-time clinical trial data. This technology is
already being used by more than 4,000 patients in 36 countries
and forms a central plank of our 'moonshot' aspiration of being
able to submit new products for market authorisation in four
key markets within four days of the last patient visiting a pivotal
trial site.
This is a journey that will take time to complete, but it is already
creating an innovative pipeline of differentiated projects that
has the potential to secure long-term sustainable growth of our
offering to patients beyond 2030.
In the meantime, our R&D is continuing to deliver significant
advances. Major milestones in the past year include the US
approval of Wegovy® - a pivotal new treatment of obesity
and the initiation of phase 3 clinical trials investigating oral
semaglutide for both obesity and Alzheimer's disease.
Entering a new century of diabetes innovation
In the 101 years since the discovery of insulin, there have been
many advances in the treatment of diabetes, yet the number of
people living with the condition continues to climb. As a result,
there remains an urgent need for better, more patient-focused
therapies to continue to reduce the burden of diabetes.
Our potential future treatment and device innovations may offer
this step change in care. They include the once-weekly basal
insulin icodec, which entered final-stage phase 3 development
in November 2020, which has the potential to offer patients
greater convenience than the current option of once-daily basal
insulins. We have also progressed our work on glucose-sensitive
insulin, which is designed to activate when glucose levels rise,
thereby potentially providing better disease control and a lower
risk of hypoglycaemia.
Beyond insulin, we have continued the rollout of RybelsusⓇ, our
once-daily oral GLP-1 therapy, while once-weekly semaglutide
2.0 mg for type 2 diabetes received a positive opinion
recommending marketing authorisation in the EU in November
2021, and has been re-submitted for US regulatory approval
following the receipt of a Refusal to File letter from the US Food
& Drug Administration in March 2021. We have also launched
two phase 2 trials investigating fixed-dose combination
therapies for type 2 diabetes - one focusing on semaglutide
in combination with cagrilintide (which is also being explored
Moustapha Djamil Cissé is living with type 1 diabetes
and is enrolled in our Changing Diabetes in Children
programme, Senegal
for patients living with obesity), and the other looking at
combination of semaglutide and GIP (gastric inhibitory
polypeptide).
Leading the treatment of obesity
We are making major strides in tackling obesity, both with the
successful launch of our pioneering injectable GLP-1 product
WegovyⓇ in the US and the advancement in our pipeline of
next-generation therapies that we hope will deliver even greater
weight loss efficacy.View entire presentation